The Food and Drug Administration (FDA) stated on Feb. 24 that Johnson & Johnson’s single-dose vaccine prevents COVID-19 and that the FDA will make a final authorization decision soon.
Johnson & Johnson has an ongoing study of 44,000 patients in South Africa, the United States, and several other countries, with seven deaths recorded among patients receiving a placebo—and none among those who got the vaccine.
“There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,” the FDA analysis stated.
SARS-CoV-2 is another name for the CCP (Chinese Communist Party) virus, which causes COVID-19.
The Johnson & Johnson vaccine efficacy against moderate to severe COVID-19 cases was 66.9 percent at least 14 days after the single-dose vaccination and 66.1 percent at least 28 days after the shot was administered, the FDA stated in the new document, which was submitted to the agency’s Vaccines and Related Biological Products Advisory Committee.
The committee, which offers nonbinding recommendations on vaccines and other products, is scheduled to meet on Feb. 26 to discuss Johnson & Johnson’s vaccine candidate.
FDA authorization could come as soon as the following day.
Johnson & Johnson has stated that the vaccine was 72 percent effective in the United States but less effective elsewhere. The candidate was only 57 percent effective against the virus in South Africa, where a new and more contagious variant has emerged in recent months.
The FDA also said it reviewed data for the vaccine, saying it is “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”
Only two vaccines are currently authorized for emergency use in the United States, one from Moderna and one from Pfizer. They have an efficacy of 94.1 percent and 95 percent, respectively, according to studies.
Both require two doses for full protection, making Johnson & Johnson’s an attractive third option if drug regulators decide to greenlight its distribution and administration.
More than 65 million doses have been administered in the United States as of Feb. 23, according to federal data. But President Joe Biden’s administration has pushed to get more doses administered faster in a bid to bring life back to normal after a year of harsh restrictions.
A Johnson & Johnson official told members of Congress this week that the company projects having enough vaccine to inject more than 20 million Americans by the end of April.
“Assuming necessary regulatory approvals relating to our manufacturing processes, our plan is to begin shipping immediately upon emergency use authorization, and deliver enough single-doses by the end of March to enable the vaccination of more than 20 million Americans,” Richard Nettles, vice president of U.S. medical affairs for a portion of Johnson & Johnson, told the House Energy and Commerce Committee on Feb. 23.
Jeffrey Zients, Biden’s COVID-19 response coordinator, told reporters in a virtual briefing on Feb. 24 that the administration expects to allocate 3 million to 4 million doses of the vaccine next week if it’s approved.
“We will waste no time getting this life-saving vaccine into the arms of Americans,” he said.